Recall Z-0889-2022— Brius Technologies Inc.
Class II · Terminated
Class II FDA medical device recall by Brius Technologies Inc., initiated 2022-02-07, terminated 2024-10-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL. Reason: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released..
- Recalling firm
- Brius Technologies Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-07
- Terminated
- 2024-10-18
- Firm location
- Carrollton, TX, United States
Product description
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Reason for recall
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Data sourced from openFDA. This site is unofficial and independent of the FDA.